Documents of external origin are considered to be regulations, laws, binding and/or applicable regulations, technical standards and any other public or private act necessary for the development and implementation of the Quality Management System as well as the production/provision of the service.

Examples of such documents include ISO 13485:2016 or other standards used in medical device design and development, certificates issued by Notified Bodies and Regulatory Authorities or other documents containing regulatory requirements and customer information.

The list of documents of external origin contains the list of laws, standards and regulations demonstrating that the organisation transposes product and system regulatory requirements according to the state of the art. This document is subject to control by Notified Bodies, Certifying Bodies and Regulatory Authorities.